MAUDE Adverse Event Report: MATRIX SURGICAL USA OMNIPORE SURGICAL IMPLANT; CRANIAL IMPLANT

Model Number 89020

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

Patient got an infection following implantation.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

Patient got an infection following implantation.

Manufacturer Narrative

Multiple attempts for additional information were made to no avail.Manufacturing records were not reviewed as the lot number was not provided.A definitive root cause could not be established as pertinent information was unable to be obtained.Additionally, infection is a known risk inherent risk of any surgical procedure.The instructions for use list superficial and/or deep infection as a possible adverse event.

• Brand Name: OMNIPORE SURGICAL IMPLANT
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): MATRIX SURGICAL USA; 4025 welcome all rd. ste #120; atlanta GA 30349
• Manufacturer Contact: darren troutman ; 4025 welcome all rd. ste# 120; atlanta, GA 30349 ; 4048554592
• MDR Report Key: 14597475
• MDR Text Key: 293309347
• Report Number: 3009383407-2022-00001
• Device Sequence Number: 1
• Product Code: MVA
• UDI-Device Identifier: 00855421005406
• UDI-Public: 00855421005406
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 89020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization